Marken presented a case study at the Cell & Gene Therapy Europe Conference in Barcelona, which focused on a global, multi-centered cell-based therapy trial involving nearly 1,000 patients in over 20 countries. The trial requires shipments of bio-hazardous material derived from patient samples, which are transported in liquid nitrogen containers but must reach the manufacturing site within 28 hours of the patient visit. The logistics of preparing the samples, transporting them across country borders, delivering them within stability, manufacturing a patient-specific vaccine and finally delivering the treatment to a patient are a complex undertaking.
These gene- or cell-based, bio-hazardous materials require special handling under cryogenic conditions. In addition, the regulations for handling the shipments can vary from country to country which makes supply chain planning a highly specialized service. Marken's broad network and expertise help clients to define and mitigate risks when planning their clinical trials.
"We see a continuing increase in requests for gene and cell therapy trials and will continue to invest in our infrastructure by expanding our transport and storage using liquid nitrogen shippers at minus180 degrees Celsius. We believe we are the first logistics company to offer liquid nitrogen storage capabilities for clinical trials on a global scale," said Wes Wheeler, chief executive officer, Marken.
